Assessment of Efficacy of a Psychological Therapy in Inpatients With a Schizophrenic Psychosis

NCT03316664 | Completed DMC

• 1 other identifier: CBTSZ
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

This randomised three-arm study aims to evaluate the efficacy and feasibility of a cognitive behavioral therapy (INT-Integrated Neurocognitive Therapy for Schizophrenia Patients) in the treatment of schizophrenia patients in an inpatient setting. The intervention will be compared with an active comparator (IPT- Integrated Psychological Therapy) and a control condition. Overall the study will include 90 patients (30 in each arm). Each patient will receive at least 16 sessions of the respective treatment. Baseline and follow up assessments up to 12 months after the intervention will investigate the stability of treatment.

Conditions

Schizophrenia; Schizoaffective Disorder; Psychotic Disorders

Keywords

cognitive behavioural therapy; psychotic disorder; schizophrenia; schizoaffective disorder; psychological intervention

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Symptomatology at 12 Months.

  The "Positive and Negative Syndrome Scale" (PANSS) was designed to measure the severity of psychopathology in adult patients with a psychotic disorder, mainly schizophrenia and schizoaffective disorder.

  Baseline, 2 Weeks, 10 Weeks, 6 Months, and 12 Months.

Secondary Outcomes (1)

• Change from Baseline Symptomatology at 12 Months.

  Baseline, 2 Weeks, 10 Weeks, 6 Months, and 12 Months.

Study Arms (3)

INT

EXPERIMENTAL

Integrated Neurocognitive Therapy (INT) is a manualized psychological intervention that consists of 30 sessions administered by a therapist and a co-therapist in an open group of 6-8 patients. Sessions will take place twice a week, and each session should last 90 min.

Behavioral: Integrated Neurocognitive Therapy (INT)

IPT

ACTIVE COMPARATOR

Integrated Psychological Therapy (IPT) is a manualized psychological intervention that consists of 5 modules which can be completed in a variable number of sessions that will be administered by a therapist and a co-therapist in an open group of 6- 8 patients. Sessions will take place twice a week, and each session should last 60 to 90 min.

Behavioral: Integrated Psychological Therapy (IPT)

CoC

OTHER

COGPACK is a computer-based neuropsychological cognitive training program. It will be administered by a trainer in an open group of 6- 8 patients. Sessions will take place twice a week, and each session will last 45 - 60 minutes.

Other: COGPACK

Interventions

Integrated Neurocognitive Therapy (INT) BEHAVIORAL

Information already included in arm/group description.

INT

Integrated Psychological Therapy (IPT) BEHAVIORAL

Information already included in arm/group description.

IPT

COGPACK OTHER

Information already included in arm/group description.

CoC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are competent to give informed consent.
• Diagnosis of Schizophrenia or Schizoaffective Disorder (ICD-10).
• Participants are between 18 and 65 years of age.
• Fulfillment of regular compulsory education.
• German language proficiency as a native speaker or level B1

You may not qualify if:

• Unwilling or unable to comply with study instructions.
• Low Intelligence as stated by failure to accomplish regular compulsory education.
• Currently in another psychotherapeutic treatment, either in individual or group sessions.
• Current consumption of Alcohol or illicit Drugs.

Sponsors & Collaborators

• Psychiatric University Hospital, Zurich: lead

Study Sites (1)

Psychiatrische Universitätsklinik Zürich

Zurich, 8032, Switzerland

Location

Related Publications (1)

• Redlich Bossy M, Mueller D, Seifritz E, Vetter S, Egger ST. Feasibility and Efficacy of a Psychological Therapy for Patients With a Schizophrenic Psychosis in an Inpatient Setting: Study Protocol of a Randomized Switch Controlled Trial. Front Public Health. 2020 Aug 12;8:391. doi: 10.3389/fpubh.2020.00391. eCollection 2020.

  PMID: 32903368 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: An 8-week, randomized, controlled, assessor-blind, three-parallel-arm trial is planned with patients diagnosed with a schizophrenic psychosis.

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 20, 2017
• Study Start: June 1, 2018
• Primary Completion: July 31, 2021
• Study Completion: August 31, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)